Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Recalled by Excelsior Medical Corp Due to There is a potential for a leak. A...

Date: June 5, 2014
Company: Excelsior Medical Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Excelsior Medical Corp directly.

Affected Products

Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer

Quantity: 4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))

Why Was This Recalled?

There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Excelsior Medical Corp

Excelsior Medical Corp has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report